Eli Lilly and Company — Inluriyo (imlunestrant) $LLY

for adult patients with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy (in combination with Verzenio/abemaciclib)

NDA · Standard Review

FDA approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) on September 18, 2026 for adults with ER+/HER2-/ESR1-mutated advanced or metastatic breast cancer after progression on ≥1 line of endocrine therapy. First-ever FDA approval of imlunestrant. Guardant360 CDx approved concurrently as the required companion diagnostic. Phase 3 EMBER-3: mPFS 11.1 vs 5.5 months (imlunestrant + abemaciclib vs imlunestrant alone), ORR 35% vs 15%.